Human Follicular Fluid Markers and Reproductive Outcomes in IVF

Janna Pape

Status: Enrolling

Conditions: Infertility; IVF

Treatments: Procedure: Natural cycle In Vitro Fertilisation (IVF); Diagnostic Test: Sperm samples for analysis; Procedure: Conventional In Vitro Fertilisation (IVF); Diagnostic Test: Follicular fluid for analysis; Diagnostic Test: Blood samples for analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05893238

KEK Bern 2022-00944

Details and patient eligibility

About

The goal of this observational study is to understand the processes in the growing follicles development in more detail and to improve In Vitro Fertilisation (IVF) treatments. This involves measuring laboratory values in the blood, in the follicular fluid of the woman and in the sperm of the man as well as questionnaires concerning lifestyle factors. These values are then linked to the success of the fertility treatment to find out which of these values increase the success of the IVF treatment.

Furthermore, the investigators want to investigate if there are differences between IVF treatments with or without hormonal stimulation of the ovaries.

Full description

This is a one-site prospective exploratory study at the University Clinic for Gynaecological Endocrinology and Reproductive Medicine in Bern. Data of influencing factors on IVF success in women and men will be collected in two types of IVF treatment, i.e. with or without hormonal stimulation of the ovaries.

The investigators want to

• compare the follicular fluid values between the two IVF treatment groups.
• assess the associations and predictive power of follicular fluid / blood and sperm parameters for success of the IVF treatment.
• compare the IVF success in the two treatment groups. The study aims to enrol approximately 200 couples. The data will be collected by the physicians and added to the REDcap study registry. Access to the total data set is only permitted for the principal investigator.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to participate
• Written consent
• Couples undergoing In Vitro Fertilisation (natural cycle or conventional IVF)

Exclusion criteria

• Not willing to participate
• Missing consent
• Female of the couple does not want to participate or missing consent
• Language barrier
• Medical freezing
• Social freezing
• Thawed cycles
• Genetic disorders
• Preimplantation genetic testing (PGT)
• Medication for chronic condition
• Surgery in the last 4 weeks
• Significant trauma in the last 90 days
• Severe reduced sperm quality
• Kryosperm
• Poor responder or expected poor response

Trial design

200 participants in 2 patient groups

In Vitro Fertilisation (IVF)-Patients without hormonal stimulation (Natural cycle IVF)

Description:

Natural cycle IVF

Treatment:

Diagnostic Test: Follicular fluid for analysis

Diagnostic Test: Blood samples for analysis

Diagnostic Test: Sperm samples for analysis

Procedure: Natural cycle In Vitro Fertilisation (IVF)

In Vitro Fertilisation (IVF)-Patients with hormonal stimulation (conventional IVF)

Description:

conventional IVF

Treatment:

Procedure: Conventional In Vitro Fertilisation (IVF)

Diagnostic Test: Follicular fluid for analysis

Diagnostic Test: Blood samples for analysis

Diagnostic Test: Sperm samples for analysis